WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) had evidence before approving the cholesterol drug Crestor that it caused an increased incidence of rhabdomyolysis (severe muscle deterioration), yet the agency approved it anyway, erroneously believing that this toxicity was limited to an 80 milligram dose that was not ultimately approved, Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, writes in this week’s issue of The Lancet (June 26).

The approval came despite the fact that agency officials had said that any new cholesterol drug should be approved only if it has a comparable or lower risk of rhabdomyolysis than drugs already on the market. In fact, records show that patients taking Crestor experience severe muscle deterioration at much higher rates than patients taking other cholesterol-lowering drugs. The rate of post-marketing reports of rhabdomyolysis for Crestor appears to exceed that of all other currently marketed statins (cholesterol-lowering drugs). Also, the drug is associated with primary kidney failure.

From the time of its approval in August 2003 to mid-April, 18 patients, including 11 in the United States, suffered severe muscle deterioration. In addition, there have been eight reported cases of acute kidney failure and four of kidney insufficiency, according to data obtained from the FDA. Most of these patients were using the low 10 milligram dose. More than 20 additional cases of rhabdomyolysis have been reported to the FDA since mid-April, agency sources say.

In March, Public Citizen filed a petition with the FDA to have the drug taken off the market. The petition is still pending. Meanwhile, AstraZeneca has launched a major direct-to-consumer advertising campaign to promote the drug.

Crestor is the only statin that exhibited rhabdomyolysis before being approved by the FDA.